BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT

    MDR report key: 19931427 · Received August 7, 2024

    Report

    Report Number
    3012236936-2024-000216
    Event Type
    Injury
    Date Received
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-2 PATIENT AGE: YEARS - MEAN (SD): 71.2 (8.3) SECTION A-3A PATIENT SEX: # PATIENTS (%TOTAL): FEMALE - 15 (56%) AND MALE 12 (44%) SECTION A-3B PATIENT GENDER: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-4 PATIENT WEIGHT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-5 PATIENT ETHNICITY: # PATIENTS (%TOTAL): BLACK 25 (93%) AND NON-HISPANIC WHITE 02 (7%) SECTION A-6 PATIENT RACE: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION B-3: DATE OF EVENT: 11-OCT-2023 (DATE ARTICLE WAS ACCEPTED). SECTION D-4 MODEL NUMBER: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 CATALOG NUMBER: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 DEVICE SERIAL NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-4 DEVICE EXPIRATION DATE: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 UDI NUMBER: THE UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: DEVICE SERIAL NUMBER IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. SECTION H-4 DEVICE MANUFACTURE DATE: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 4471 - INADVERTENT EARLY LIGATURE DISSOLUTION POW4 (N=1 EYE) AND POW5 (N=1 EYE), BOTH HAD SELF-LIMITED REFLUX HYPHEMAS. CITATION: KANTER JA, KHANNA S, THEOPHANOUS C, SI Z, QIU M. BAERVELDT-350 WITH ADJUNCTIVE GONIOTOMY: PILOT RESULTS. AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS. 2023 DEC 1;32:101950. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: BAERVELDT-350 WITH ADJUNCTIVE GONIOTOMY: PILOT RESULTS. A RETROSPECTIVE CHART REVIEW WAS DONE TO DESCRIBE A PREVIOUSLY UNREPORTED METHOD FOR OPTIMIZING EARLY INTRAOCULAR PRESSURE-LOWERING IN NON-VALVED AQUEOUS SHUNT SURGERY, AND TO REPORT PILOT RESULTS FROM A CASE SERIES. A TOTAL OF 40 EYES INCLUDED HAD UNDERGONE ADJUNCTIVE GONIOTOMY FOR 90¿120 AT THE TIME OF FIRST SUPEROTEMPORAL BGI-350 IMPLANTATION. TUBES WERE FENESTRATED VIA 3 PUNCTURES WITH THE SE-160-8 SPATULATED NEEDLE ATTACHED TO THE 7- 0 POLYGLACTIN LIGATURE; NO WICK WAS USED. A 3-0 PROLENE RIPCORD WAS ALWAYS PLACED AND NOT INTENDED TO BE REMOVED PRIOR TO SPONTANEOUS LIGATURE DISSOLUTION. EYES WITH MISSING POSTOP WEEK 4 DATA (13%) OR HISTORY OF UVEITIS (8%) OR TRAUMA (5%) WERE EXCLUDED. OVERALL, 27 PATIENTS (N= 30 EYES) WERE INCLUDED IN THIS ANALYSIS; 83% OF EYES HAD PRIMARY OPEN ANGLE GLAUCOMA. THERE WAS 1 PATIENT LOST TO FOLLOW-UP AT POSTOP MONTH 4 (POM4). EVENTS INCLUDED: HYPHEMA: POSTOP DAY 1 (POD1) (N=7 EYES); POSTOP WEEK 1 (POW1) (N=2 EYES); ALL WERE SELF-LIMITED. INADVERTENT EARLY LIGATURE DISSOLUTION: POW4 (N=1 EYE); POW5 (N=1 EYE); BOTH HAD SELF-LIMITED REFLUX HYPHEMAS IOP SPIKES (>30 MMHG) AT POW1 (N=1) DUE TO MEDICATION NON-ADHERENCE. ADVERSE EVENTS, HYPHEMA AND INADVERTENT EARLY LIGATURE DISSOLUTION, ARE PROCEDURAL COMPLICATIONS AND ARE DEEMED HIGHLY UNLIKELY TO BE RELATED TO OUR DEVICE BASED ON INITIAL MEDICAL ASSESSMENT. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573773 UNK_GLAUCOMA SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other